title: [Method validation according to ISO 15189 and SH GTA 04: application for the extraction of DNA and its quantitative evaluation by a spectrophotometric assay].
abstract: According to the French legislation on medical biology (January 16th, 2010), all biological laboratories must be accredited according to ISO 15189 for at least 50% of their activities before the end of 2016. The extraction of DNA from a sample of interest, whether solid or liquid is one of the critical steps in molecular biology and specifically in somatic or constitutional genetic. The extracted DNA must meet a number of criteria such quality and also be in sufficient concentration to allow molecular biology assays such as the detection of somatic mutations. This paper describes the validation of the extraction and purification of DNA using chromatographic column extraction and quantitative determination by spectrophotometric assay, according to ISO 15189 and the accreditation technical guide in Human Health SH-GTA-04.
authors.affiliation: Service de biopathologie, Institut de cancérologie de Lorraine, Vandœuvre-lès-Nancy, France, CNRS, UMR 7039 CRAN, Nancy, France, Université de Lorraine, Nancy, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Harlé
authors.forename: Maëva
authors.initials: M
authors.lastname: Lion
authors.forename: Marie
authors.initials: M
authors.lastname: Husson
authors.forename: Cindy
authors.initials: C
authors.lastname: Dubois
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Merlin
mesh_terms: D000068:Accreditation / Q000331:legislation & jurisprudence*; D001800:Blood Specimen Collection / Q000592:standards*; D002458:Cell Fractionation / Q000379:methods / Q000592:standards*; D064790:Clinical Laboratory Services / Q000331:legislation & jurisprudence / Q000592:standards; D004247:DNA / Q000032:analysis*; D059018:DNA Contamination; D005602:France; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods / Q000592:standards; D011518:Proto-Oncogene Proteins / Q000235:genetics; D016283:Proto-Oncogene Proteins p21(ras); D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013053:Spectrophotometry / Q000379:methods / Q000592:standards; D035501:Uncertainty; D018631:ras Proteins / Q000235:genetics
chemical_list: C117307:KRAS protein, human; D011518:Proto-Oncogene Proteins; D004247:DNA; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins
keywords: DNA; ISO 15189; certification; extraction